Glioblastoma Clinical Trial
Official title:
Phase I Trail of Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) Plus Irinotecan (CPT-11) (NSC 616348) in the Treatment of Patients With Recurrent / Progressive Cerebral Anaplastic Gliomas
Objectives:
To determine maximum tolerated dose of CPT-11 when administered following Temodar plus
O6-benzylguanine To characterize any toxicity associated w combo of CPT-11 + Temodar plus
O6-BG To observe pts for clinical antitumor response when treated w combo of CPT-11 +
Temodar + O6-BG
Objectives of study: to determine maximum tolerated dose of CPT-11 when administered
following Temodar + O6-benzylguanine (O6-BG); to characterize any toxicity associated w
combo of CPT-11 + Temodar + O6-BG; to observe pts for clinical antitumor response when
treated w combo of CPT-11 + Temodar plus O6-BG. Pts have histologically confirmed diagnosis
of recurrent primary malignant glioma. 2 separate strata accrued independently of each
other: Stratum 1-pts receiving Dilantin, Tegretol/phenobarbital. Stratum 2-pts on
anti-convulsants other than Dilantin, Tegretol/phenobarbital/pts not on any
anti-convulsants. Each strata will be treated & escalated independent of each other.
Pre-chemo, O6-BG administered intravenously at 120 mg/m2, over 1hr, prior to administration
of Temodar on day 1 of 21-day cycle. Post-chemo, O6-BG administered intravenously at 30
mg/m2/day, over 48hrs, immediately after completion of the CPT-11 infusion on day 1 of
21-day cycle. Temodar administered orally at 355 mg/m2, in fasting state, within 60 minutes
of the end of 1hr O6-BG infusion. Treatment cycles may be repeated every 3 weeks following
dose of Temozolomide from previous cycle. CPT-11 will be administered intravenously in
fasting state over 90min. CPT-11 infusion will begin 1hr after Temozolomide administration.
Initial doses 60 mg/m2 for stratum 1 & 40 mg/m2 for stratum 2. Treatment cycles may be
repeated every 3 wks following dose of CPT-11 from previous cycle.
Major toxicities associated w CPT- 11 are myelosuppression & diarrhea. Temozolomide has been
well tolerated by both adults & children w most common toxicity being mild myelosuppression.
Other, less likely, potential toxicities include nausea & vomiting, constipation, headache,
alopecia, rash, burning sensation of skin, esophagitis, pain, diarrhea, lethargy, &
hepatotoxicity. Hypersensitivity reactions have not yet been noted w Temozolomide. As is
case w many anti-cancer drugs, Temozolomide may be carcinogenic. O6-BG toxicities include
transient lymphopenia has been seen w O6-BG as single agent. O6-BG in combo w other agents
could cause exacerbation of any adverse event currently known to be caused by other agent,/
combo may result in events never previously associated w either agent. Animal studies
indicated that agitation, lethargy, convulsions, nausea, vomiting, rapid heart rate,
elevated liver functions, leukopenia, lymphopenia could be seen.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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